BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EchoSure

    Reg #: 3014680735 · FEI: 3014680735 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SONAVEX, INC.
    Registration Number
    3014680735
    FEI Number
    3014680735
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2835 ODONNELL ST STE 200
    City
    Baltimore
    State
    MD
    ZIP
    21224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190039

    Owner / Operator

    Firm Name
    Sonavex, Inc.
    Operator Number
    10057900
    Address
    2835 O'Donnell Street, Suite 200
    City
    Baltimore
    State
    MD
    Postal Code
    21224
    Country
    US
    Correspondent
    David Narrow

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    EchoSure

    Establishment Types

    Manufacture Medical Device